The university had numerous opportunities to comment before the story was published and has not contacted KyCIR to challenge the story or any of the documented findings in it since its publication on Monday. Still, we want to address their claims in detail.

Federal funding was withdrawn from the study in question; our story details this and includes the source document from a federal department within the U.S. Department of Health and Human Services. The March 18 letter reads, in part: “[The agency] has decided that we will discontinue funding for this particular study, effective immediately.”

U of L claims none of the 151 “adverse events” referred to in our story were the result of the research. Our story does not make the counterclaim.

U of L also claims “medication compliance was taking place” and suggests it was a minor deviation. Our story reported that research records did not contain information about patients’ medical compliance, quoting the letter from HHS noting that as a major concern. Again, that source document is contained within the story.

March 18 letter from HHS to University of Louisville

KyCIR also provided the source documents for the story for review by three outside experts without ties to U of L, all of whom drew the same conclusions that are reflected in the story. Among those was Dr. Milton Corn, deputy director for research and education at the National Library of Medicine, who is quoted in the story.

We also provided the documents to several additional experts not quoted in the story who drew the same conclusions.

Beginning on June 22, we attempted to interview William Pierce, executive vice president for research and innovation at U of L, who co-authored the U of L letter. He declined to comment, which is reflected in the story. He declined comment on the matter again on Wednesday. We also attempted to get comment from the university’s Institutional Review Board, which conducted the audit; they declined. (Read the institutional review board’s audit report.)

And we gave the spokesperson for U of L’s Health Sciences Center an opportunity to discuss our findings three days before the story was published, but that person did not.

Perhaps most importantly, Dr. Susan Harkema — whose study is the subject of the story — is quoted throughout responding to our findings.

Harkema’s defense, as well that of Pierce and the university, is based upon the claim that alleged disgruntled employees brought negative and false information about her and the study to light. While one employee is named and quoted in our story, our reporting relied on federal and university documents which are, again, posted in full with the story.

The suggestion from U of L that our story contains inaccuracies of any kind is false and egregious, and is a transparent attempt to deflect recent attention arising from our reporting. We encourage anyone interested to compare their claims to our story and the original source documents and draw their own conclusions.